510(k) Report

Devices descending from K102293

869 later devices reach Caliber Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K201087CORBEL SpacersGlobus Medical, Inc.202036—
+2K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+2K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K190488ProLift Expandable SystemLife Spine, Inc.201916—
+2K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+2K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+2K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+2K181397DualXInnovasive, Inc.201815—
+2K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K172480icotec Interbody Cage SystemIcotec AG20185—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K171425Concorde LiftMedos International SARL201782
+2K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+2K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153786Prow Fusion-VNlt Spine, Ltd.20166—
+2K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+2K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+2K153400ProLift Expandable SystemLife Spine, Inc.201672—
+2K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+2K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+2K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+2K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+2K133207Staxx (R) SystemSpine Wave, Inc.20131—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+2K130194Acculif XL CageCoalign Innovations, Inc.20131—
+2K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+2K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+2K122097Patriot SpacersGlobus Medical, Inc.2012261—
+2K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261430TruLift Expandable SystemLife Spine, Inc.20260—
+3K2530413d Cage CervicalFims Co., Ltd.20260—
+3K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K261067BEE PLIF CageNGMedical GmbH20260—
+3K242303MOD-COrthomod, LLC20260—
+3K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250560BEE HANGMedical GmbH20250—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—